PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma

NCT07256158 | Not Yet Recruiting Phase 3

• 1 other identifier: FIL_PRIORITY
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 38

Brief Summary

The final analysis of GHSG HD11 study (not PET driven) showed that 30 Gy IFRT still remains the standard dose after 4 ABVD. Early PET negativity might allow safe radiation de-escalation in patients achieving a metabolic complete response after 2 ABVD. The aim of Priority trial is to explore whether radiotherapy could be safely deescalated to 20 Gy without loss of efficacy in patients treated with four cycles of ABVD who achieved complete metabolic response after the first two cycles.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma; Early stage; unfavourable; untreated; ABVD; chemotherapy; radiotherapy; 20 Gy; 30 Gy; randomization; PET guided; involved site

Outcome Measures

Primary Outcomes (1)

• To evaluate if de-escalated ISRT dose (20 Gy) is not inferior to conventional ISRT dose (30 Gy) in terms of PFS in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycle

  Progression-Free Survival (PFS) of the randomized population. Subjects with incomplete follow-up or with no disease evaluation will be censored at the date of last available documented status of freedom from failure.

  From the date of randomization to documented relapse, progression or to the patient's death as a result of any causes (up to 82 months).

Secondary Outcomes (5)

• To compare OS rates between de-escalated ISRT dose (20 Gy) and conventional ISRT dose (30 Gy) in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycles;

  From the time of randomization to death from any cause (up to 82 months)

• To evaluate PFS for the whole population

  From the date of consent to documented relapse, progression or death from any cause (up to 84 months)

• To evaluate OS for the whole population

  From the date of consent to death from any cause (up to 84 months)

• To describe pattern of failure "in field", "marginal field", "out of field" relapse after conventional and reduced ISRT;

  From the date of consent to death from any cause (up to 84 months)

• To report details on RT treatment volumes and dose distributions and to estimate the dose received by the organs at risk (OARs) in the two treatment arms

  At time of radiotherapy (about 4 months from chemotherapy start)

Study Arms (2)

Experimental arm - 20 Gy Radiotherapy

EXPERIMENTAL

Involved site radiotherapy (ISRT) Total dose of 20 Gy is administered in 10 daily fractions of 2.0 Gy, five times a week over 2 weeks

Radiation: 20 Gy Involved site radiotherapy

Comparator arm - 30 Gy Radiotherapy

ACTIVE COMPARATOR

Involved site radiotherapy (ISRT) Total dose of 30 Gy is administered in 15 daily fractions of 2.0 Gy, five times a week over 3 weeks

Radiation: 30 Gy Involved site radiotherapy

Interventions

20 Gy Involved site radiotherapy RADIATION

Total dose 20 Gy Involved site radiotherapy

Experimental arm - 20 Gy Radiotherapy

30 Gy Involved site radiotherapy RADIATION

Total dose 30 Gy Involved site radiotherapy

Comparator arm - 30 Gy Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Histologically confirmed classical HL stage I, II unfavorable according to GHSG criteria;
• Patient with any nodal mass ≥ than 10 cm can be included
• No previous treatment for Hodgkin lymphoma;
• ECOG performance status 0 to 2;
• Presence of FDG-avid lymphoma lesions on baseline PET scan;
• Subject understands and voluntarily signs the informed consent form approved by the Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures;
• Adequate organ and marrow function as defined below:
• absolute neutrophil count \> 1.0 x109/L
• platelet count \> 75 x109/L
• Total bilirubin \< 2 mg/dl without a pattern consistent with Gilbert's syndrome
• Aspartate Transaminase and Alanine Transaminase (AST/ALT) \< 3.0 X institutional Upper Limits of Normality (ULN)
• Creatinine within normal institutional limits or creatinine clearance \> 50 mL/min
• Women of childbearing potential must agree to use a highly effective method of contraception (oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) from the signature of informed consent until six months after the last dose of treatment;
• Men must agree to use a highly effective method of contraception (barrier contraception or abstinence, when this is in line with the usual lifestyle of the subject) from the signature of informed consent until six months after the last dose of treatment;

You may not qualify if:

• Patients who meet any of the following criteria are not eligible to enroll:
• Stage II B- III- IV
• Hodgkin Lymphoma as "composite lymphoma" or nodular lymphocyte prevalence histological subtype
• Active HBV and HCV infection
• HIV seropositivity
• Pre-treatment with chemotherapy or radiation therapy
• Malignant disease within the last 5 years (excluding basal skin tumors and carcinoma in situ of the cervix)
• Women who are pregnant or breast feeding
• Absence of FDG-avid lymphoma lesions on baseline PET scan
• Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (38)

A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia

Alessandria, Italy

Location

A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate

Avellino, Italy

Location

IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati

Aviano, Italy

Location

ASST Papa Giovanni XXIII - S.C. Ematologia

Bergamo, Italy

Location

Clinica Humanitas Gavazzeni - U.O. Oncologia Medica

Bergamo, Italy

Location

ASST Spedali Civili - S.C. Ematologia

Brescia, Italy

Location

ARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO

Cagliari, Italy

Location

I.R.C.C.S. Istituto di Candiolo - FPO

Candiolo, Italy

Location

ARNAS Garibaldi - U.O.C. Ematologia

Catania, Italy

Location

A.O. S. Croce e Carle - S.C. Ematologia

Cuneo, Italy

Location

A.S.L. Toscana Centro - SOC Oncoematologia

Florence, Italy

Location

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, Italy

Location

IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari

Genova, Italy

Location

ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto

Latina, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

Milan, Italy

Location

IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia

Milan, Italy

Location

A.O.U. Ospedale Maggiore della Carità - S.C.D.U. Ematologia

Novara, Italy

Location

A.O.U. di Padova - U.O.C. Ematologia

Padua, Italy

Location

I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1

Padua, Italy

Location

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

Palermo, Italy

Location

IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1

Pavia, Italy

Location

A.O. Ospedale S. Maria della Misericordia - Ematologia

Perugia, Italy

Location

AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti

Piacenza, Italy

Location

AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia

Ravenna, Italy

Location

AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia

Reggio Emilia, Italy

Location

A.O.U. Policlinico Umberto I - U.O.C Ematologia

Roma, Italy

Location

A.O.U. Sant'Andrea - U.O.C. Ematologia

Roma, Italy

Location

Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali

Roma, Italy

Location

IRCCS Humanitas - U.O. Ematologia

Rozzano, Italy

Location

IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche

San Giovanni Rotondo, Italy

Location

A.O.U. Senese - U.O.C. Ematologia

Siena, Italy

Location

A.O. Santa Maria - S.C. Oncoematologia

Terni, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U

Torino, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

Torino, Italy

Location

ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia

Treviso, Italy

Location

A.S.U. Giuliano Isontina - S.C. Ematologia

Trieste, Italy

Location

A.S.U. Friuli Centrale - Clinica Ematologica

Udine, Italy

Location

A.O.U.I. di Verona - U.O.C. Ematologia

Verona, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Umberto Ricardi, MD

  SC Radioterapia U - AOU Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uffici Studi FIL

CONTACT

+390131033153; startup@filinf.it

Uffici Studi FIL

CONTACT

+390599769913; gestionestudi@filinf.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Phase III, Non-inferiority study

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

IT (38)